Evaluation of Cerebral Thrombembolism After TAVR

Evaluation of Cerebral Thrombembolism After TAVR

Sponsors

Lead Sponsor: Charite University, Berlin, Germany

Collaborator: Bayer

Source Charite University, Berlin, Germany
Brief Summary

EARTH-TAVR is a diagnostic multicenter study to evaluate the occurrence and extent of cerebral embolization (total new lesion volume) in patients before TAVR versus 3 months after TAVR.

Detailed Description

Calcific aortic valve stenosis is the most common cause of aortic stenosis (AS) among adults in Europe and in the United States. The prevalence of moderate or severe AS was found to be age-dependent rising from 0.02% in patients aged 18-44 years to 2.8% in patients aged ≥ 75 years. Among patients at prohibitive surgical risk, TAVR has become the treatment of choice.The safety and efficacy of TAVR compared with medical management and SAVR has been demonstrated in clinical trials.The composite of the rate of all-cause death or stroke was 27% and 37% in TAVR patients after 1 and 2 years, respectively.Even though parts of the strokes occur during the peri-procedural period, the patients remain at risk of stroke throughout the first months after the procedure. EARTH-TAVR is a diagnostic multicenter study performing in association with the GALILEO trial (NCT02556203), which is investigating cerebral embolization with MRI and neurocognitive testing in patients undergoing TAVR, who are treated with anticoagulation (Rivaroxaban/ASS) or DAPT (Clopidogrel/ASS). GALILEO is a global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes. Investigators aim to investigate peri-interventional and delayed cerebral embolization in the early period (3 months) after TAVR and to analyze associations between neurocognitive parameters and cerebral embolization patterns in patients on different antithrombotic treatment regimes.

Overall Status Completed
Start Date 2016-09-01
Completion Date 2019-01-01
Primary Completion Date 2019-01-01
Study Type Observational
Primary Outcome
Measure Time Frame
Total volume of new cerebral lesions on MRI, 3 months after TAVR versus Baseline 3 months after TAVR versus baseline
Secondary Outcome
Measure Time Frame
New lesion volume of cerebral embolization in patients treated with ASS and rivaroxaban 10mg OD versus an antiplatelet -based strategy with ASS and clopidogrel. 3 months post TAVR versus baseline
extent and location of new cerebral lesions early AFTER TAVR and after 3 months MRI after TAVR (0-7 days after TAVR) compared to 3 months after TAVR
Assessment of different neurocognitive tests (NIHSS-score, MOCA-score, MOT-score, PAL-score, RTI-score, SWM-score, AST-score, CAM-Score); change of sum scores before, after and 3 months after TAVR procedure. Before TAVR, post TAVR and after 3 months
Extent and localization of clinically apparent non-cerebral emboli after TAVR baseline, post TAVR and after 3 months
Evaluation of possible changes in quality of life after TAVI with EQ-5D questionnaire sum score. Baseline versus 3 months following TAVR
Enrollment 55
Condition
Intervention

Intervention Type: Other

Intervention Name: MRI, neurocognitive Testing

Description: A cerebral MRI and neurocognitive testing will be performed before TAVR, before hospital discharge and after 3 months

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - Man or woman of 18 years of age or older - Via iliofemoral or subclavian access - Provide written IC Exclusion Criteria: - Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant Treatment - Any other indication for continued treatment with any oral anticoagulant (OAC) - Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma) - Any indication for dual-antiplatelet therapy (DAPT) for more than 3 months after randomization (such as coronary, carotid or peripheral stent implantation) - Clinically overt stroke within the last 3 months - Planned coronary or vascular intervention or major surgery - Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher - Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy - Any contraindication for cerebral MRI, in particular: - non-MRI-conditional pacemakers - MRI conditional pacemakers <4 weeks after implant - any metal fragments in the eye - aneurysm clip in the brain - severe claustrophobia

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Charité - Universitätsmedizin Berlin, Campus Mitte | Berlin, 10117, Germany
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin | Berlin, 12203, Germany
Location Countries

Germany

Verification Date

2019-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Charite University, Berlin, Germany

Investigator Full Name: Ulf Landmesser

Investigator Title: Prof. Dr. Ulf Landmesser

Keywords
Has Expanded Access No
Condition Browse
Acronym EARTH - TAVR
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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